Dyspepsia, Functional Bloating, Irritable Bowel Syndrome
Conditions
Brief summary
Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical. Aim. To prove the efficacy of a non-instrumental biofeedback technique for the treatment of abdominal distension. Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal. Intervention. Patients will be randomized into biofeedback in placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period. Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
Interventions
BEHAVIORALBiofeedback
Three sessions of biofeedback intervention will be performed during the first 3 weeks of the intervention period. Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
BEHAVIORALPlacebo
Three sessions of placebo intervention will be performed during the first 3 weeks of the intervention period. Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* episodes of visible abdominal distension triggered by meal ingestion * patients are able to identify the offending foodstuff
Exclusion criteria
* organic cause detected by clinical work-up * constipation * abdominal distension not confirmed by the 7-day clinical questionnaires or after the probe meal in the pre-intervention evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensation of abdominal distension | 4 weeks | Sensation score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in girth produced by the probe meal | 4 weeks | Abdominal girth will be measured using a non-stretch belt that is placed over the umbilicus before and after the probe meal. The response to the meal will be measured before and after treatment. |
| Effect of probe meal on sensation of abdominal distension | 4 weeks | Sensation score measured by scales graded from 0 (not at all) to 10 (very much) after the probe meal. The response to the meal will be measured before and after the intervention. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Follow-up after biofeedback | 6 months | Sensation of abdominal distension measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period at 1, 3 and 6 months after biofeedback treatment |
Countries
Spain
Outcome results
None listed